Home / Facilities / 3010479596

Samsung Biologics Co., Ltd. FDA Inspection Record

FEI 3010479596 · Inspections, Form 483s, warning letters and import refusals

Samsung Biologics Co., Ltd. is an FDA-registered facility (FEI 3010479596) located in South (KOR). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; PACK. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Sep 1, 2023: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
5 in FDA's reading room
Import refusals
3

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 1, 2023Voluntary Action Indicated (VAI)No citations listed
Feb 28, 2023Voluntary Action Indicated (VAI)No citations listed
Nov 1, 2019Voluntary Action Indicated (VAI)Procedure Deviations Recorded and Justified (21 CFR 211.100(b))
Jun 26, 2018Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date May 27, 2025, which is not always the inspection or issue date. Published by FDA Oct 26, 2026.
  • 483 on FDA.gov
    FDA listing date Sep 1, 2023, which is not always the inspection or issue date. Published by FDA Oct 17, 2023.
  • 483 on FDA.gov
    Inspection Jun 2, 2022 to Jun 9, 2022 (dates printed on the document). FDA listing date Jun 9, 2022. Published by FDA Jul 15, 2024.
  • 483 on FDA.gov
    FDA listing date Aug 24, 2021, which is not always the inspection or issue date. Published by FDA Jul 15, 2024.
  • 483 on FDA.gov
    Inspection Jul 21, 2017 to Jul 25, 2017, issued Jul 25, 2017 (dates printed on the document). FDA listing date Jul 25, 2017. Published by FDA Jul 11, 2024.

FDA record score

9 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAISep 1, 20236 x 0.63.6
Inspection classified VAIFeb 28, 20236 x 0.63.6
Inspection classified VAINov 1, 20196 x 0.251.5
Inspection classified VAIJun 26, 2018Only the 3 most recent VAI inspections add points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

Reviewing Samsung Biologics Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Samsung Biologics Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Samsung Biologics Co., Ltd.
Location
South (KOR)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; PACK
Source
decrs

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.